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Registrar's Lab Request Form

Registrar's Lab Request Form

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well good afternoon and thank you for joining me today I want to take some time and talk about addressing change in devices and how to handle regulatory change my name is Audrey Turley and I've worked with nasim laboratories now for over 20 years and I spent the last 17 of those years doing biocompatibility so we're really gonna focus on addressing change and how it relates to biocompatibility so before we get too heavy into the conversation today I really wanted to take a minute to clarify that we're always talking about risk when we talk about biocompatibility as much change is happening we're not changing that portion it's still a conversation based on the risk of the materials and the processing of the device so this is just a reminder from 1093 we're in the title it specifically says it's an evaluation and testing within a risk management process and the US fda and their guidance document on how to use 10 9 9 3 part 1 has a w

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